Clinical trial
The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: An Open-label, Randomized Clinical Trial in Brazil
Name
40068714.1.0000.5558
Description
Mucocutaneous leishmaniasis is endemic in the central region of Brazil and other countries worldwide. The standard treatment with meglumine antimoniate has a high rate of important adverse effects. This interventional study consists in a randomized clinical trial to access efficacy and safety of the association of miltefosine and pentoxifylline compared to meglumine antimoniate and pentoxifyline.
Trial arms
Trial start
2015-08-01
Estimated PCD
2025-08-01
Trial end
2026-08-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Meglumine antimoniate
20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days.
Arms:
Group 1 - Mucosal Antimoniate and Pentoxifylline, Group 3 - Cutaneous Antimoniate and Pentoxifylline
Miltefosine
Miltefosine 2,5mg/kg/day up to 50mg 2x/daily.
Arms:
Group 2 - Mucosal Miltefosine and Pentoxifylline, Group 4 - Cutaneous Miltefosine and Pentoxifylline
Other names:
Miltefosnine
Pentoxifylline
Pentoxifylline 20mg/kg/day up to 400mg 3x/daily for 28 days.
Arms:
Group 1 - Mucosal Antimoniate and Pentoxifylline, Group 2 - Mucosal Miltefosine and Pentoxifylline, Group 3 - Cutaneous Antimoniate and Pentoxifylline, Group 4 - Cutaneous Miltefosine and Pentoxifylline
Size
160
Primary endpoint
Cure
90 days
Failure
90 days
Relapse
90 days
Eligibility criteria
Inclusion Criteria:
* Mucosal and/or cutaneous leishmaniasis, not treated or at least 6 months without any treatment to leishmaniasis;
* For patients with cutaneous lesions: duration of disease longer then a 1 month and shorter then 4 yeas; 1 to 3 lesions; larger lesions from 10mm to 50mm;
* Ages between 18 and 80 years old;
* Fertile female patients should use at least two contraceptive methods (hormonal and barrier);
* Agree to participate in the study and sign the informed consent term.
Exclusion Criteria:
* Use of any leishmanicidal drugs six months prior;
* Clinical or laboratorial evidences of electrocardiographic disorders;
* Renal, hepatic, cardiac diseases, uncontrolled diabetes or AIDS;
* Hypersensitivity to meglucamine antimoniate;
* Pregnancy or lactation;
* Fertile females that do not agree to use contraceptive methods;
* Patients that do not agree to the informed consent term.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 160, 'type': 'ESTIMATED'}}
Updated at
2024-01-16
1 organization
3 products
1 indication
Organization
University of BrasiliaProduct
Meglumine antimoniateIndication
LeishmaniasisProduct
MiltefosineProduct
Pentoxifylline